Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

FDA Launches Compendium Of Clinical Outcome Assessments With Eye On Patients

This article was originally published in The Pink Sheet Daily

Executive Summary

'Pilot' document describes which measurements of patient experience have supported labeling claims, but FDA emphasizes they won't necessarily be the sole determinants.


Related Content

Duke's McClellan: Changing Drug Development Policy From Outside FDA
PDUFA VI: Price Tag For Patient Experience Data Validation May Go Up
Patient-Reported Outcomes To Be Available For ‘One-Stop Shopping’ In FDA Compendium